Study Stopped
Discontinuation of DM production by the manufacturer leading to recruitment difficulties in the centers.
Do the Head-elevated Position and the Use of a Videolaryngoscope Facilitate Orotracheal Intubation in a Patient Population Without Predictable Difficulty of Intubation
HELP-VDL
1 other identifier
interventional
121
1 country
5
Brief Summary
The main hypothesis of this study is that there is a synergy between the use of the HELP position and the use of a McGrath® Mac videolaryngoscope to facilitate tracheal intubation during anesthesia. The HELP position is the patient positioning on the AirPal RAMP, the two cushions inflated, bringing the external auditory canal to the same level as the sus-sternal notch.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedStudy Start
First participant enrolled
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2023
CompletedFebruary 12, 2025
February 1, 2025
4.3 years
June 7, 2019
February 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of oro-tracheal intubations for which it is necessary to use the assistance of a third party required by the operator
Intubation is video and audio recorded. The number of people nedeed is determined from the audio/video recording a posteriori by two independent evaluators
30 minutes
Secondary Outcomes (14)
Time to perform the intubation
30 minutes
First intubation succes rate
30 minutes
Assessment of the Quality of visualization of the glottis
30 minutes
Assessment of the Percentage of the opening of the glottic orifice
30 minutes
Assessment of quality of intubation with use of alternative techniques
30 minutes
- +9 more secondary outcomes
Study Arms (4)
Without RAMP and without video
EXPERIMENTALSniffing position and a standard Macintosh laryngoscope
With RAMP and with video
EXPERIMENTALRamped position and a McGrath Mac videolaryngoscope
Without RAMP and with video
EXPERIMENTALSniffing position and a McGrath Mac videolaryngoscope
With RAMP and without video
EXPERIMENTALRamped position and a standard Macintosh laryngoscope
Interventions
Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning without RAMP device
Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning with RAMP device
Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning without RAMP device
Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning with RAMP device
Eligibility Criteria
You may qualify if:
- Aged 18 - 89 years old
- Scheduled for elective surgical procedures
- Requiring oro-tracheal intubation for general anesthesia
- Having a telephone and agreeing to communicate their phone number in case of ambulatory surgery
- Having signed an informed consent form
- Benefiting from a social insurance
You may not qualify if:
- Pregnant or breast-feeding women
- Patients with an anticipated difficult mask ventilation or an anticipated difficult intubation (Arné's score ≥ 11)
- Patients scheduled for a surgical procedure involving the mouth or the upper airway
- Patients requiring a rapid induction sequence, the use of a double-lumen tube
- Patients having a contra-indication to one of the drug administered by the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (5)
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75012, France
Hôpital Saint-Joseph
Paris, 75014, France
Institut Mutualiste Montsouris
Paris, 75014, France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019, France
Hôpital Foch
Suresnes, 92150, France
Related Publications (1)
Le Guen M, Coppere Z, Dufour G, Ouattara J, Trichereau J, Fischler M. HELP-VDL: study protocol for a multicentre, open, randomised, controlled clinical trial comparing the use of the head-elevated laryngoscopy position and the use of a videolaryngoscope to facilitate orotracheal intubation in a patient population without predictable difficulty of intubation. BMJ Open. 2020 Jul 8;10(7):e036570. doi: 10.1136/bmjopen-2019-036570.
PMID: 32641332DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Morgan Le Guen, MD
Hôpital Foch
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2019
First Posted
June 14, 2019
Study Start
July 31, 2019
Primary Completion
November 11, 2023
Study Completion
November 11, 2023
Last Updated
February 12, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- After publication in a peer-review journal. No limit in time
- Access Criteria
- No criteria
Data will be available in the Dryad repository.